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510(k) K211024

Electric Breast Pump by Shantou Huihengqi Electronic Technology Co., Ltd. — Product Code HGX

K211024 is an FDA 510(k) premarket notification submitted by Shantou Huihengqi Electronic Technology Co., Ltd. for the device "Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on Feb 11, 2022. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 11, 2022
Date Received
Apr 6, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

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FDA data resources